In This Week’s Edition:
- FSIS Publishes Enforcement Directive on Verifying the Implementation of the 2021 Cooking Guideline And Stabilization Guideline
- AMS Issues Rule on Cattle Contracts Library Pilot Program
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
FSIS Publishes Enforcement Directive on Verifying the Implementation of the 2021 Cooking Guideline and Stabilization Guideline
FSIS has issued a notice providing instructions to inspection program personnel (IPP) on how to verify that establishments are using the revised 2021 versions of FSIS Cooking Guideline for Meat and Poultry Products and FSIS Stabilization Guideline for Meat and Poultry Products, where appropriate. Establishments that currently use the 1999 and 2017 versions of these guidelines as scientific support for their HACCP systems will need to use the 2021 version of the guidelines or identify alternative scientific support, starting December 14, 2022.
AMS Issues Rule on Cattle Contracts Library Pilot Program
AMS has issued a rule establishing the Cattle Contracts Library pilot program. Under this pilot program, the AMS will collect, maintain, and report aggregated information on contracts between packers and cattle producers for the purchase of fed cattle. The library will include different types of contracts and contract terms, including contract terms on any schedules of premiums or discounts, delivery and transportation, terms and payments, financing, risk-sharing or profit sharing, and other financial arrangements. In addition to contract term information, the Agricultural Marketing Service will also report on the number of head of cattle purchased under these contracts.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the outbreak of Listeria monocytogenes (reference #1127) linked to enoki mushrooms, FDA has initiated sample collection and analysis.
- For the outbreak of Salmonella Typhimurium (reference #1113) in an unidentified product, one additional case has been added for a total case count of 270 cases and the outbreak has ended.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include imported food products that appear to be misbranded, fishery products not in compliance with seafood HACCP, and more.
FDA Warning Letters
AG Hair Limited |
CGMP/Finished Pharmaceuticals/Adulterated |
Glenmark Pharmaceuticals Limited |
CGMP/Finished Pharmaceuticals/Adulterated |
Saffron USA LLC |
Unapproved New Drugs/Misbranded |
Cryos International USA LLC |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
Zuland Distributor Corp |
Foreign Supplier Verification Program (FSVP) |
Manzela USA, LLC |
Foreign Supplier Verification Program (FSVP) |
Maliba African Market Corp. |
Foreign Supplier Verification Program (FSVP) |
Kari Gran Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |